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Sophiris Bio, Inc. (SPHS)

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Last Post: 11/29/2016 11:38:34 AM - Followers: 132 - Board type: Free - Posts Today: 0
Sophiris Bio Inc.



Sophiris Bio Inc. is a Canadian urology company with operations based in San Diego developing a late-stage, highly targeted treatment for benign prostatic hyperplasia (BPH or enlarged prostate), a large unsatisfied market. PRX302, the company’s lead candidate for BPH, is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Sophiris is planning to begin a pivotal trial by the end of 2012.

The pivotal trial is supported by a randomized, controlled Phase IIb study that met the objective and subjective endpoints used as the basis for current BPH drug approvals. Sophiris is advised by world-leading urologists, is backed by experienced investors, and is led by an experienced drug development team that has achieved more than twenty drug approvals including several blockbusters.




 





Ongoing Clinical Development
 
Study Phase Trial Design
PLUS-1
PRX302-3-01 BPH

 

III On-going/Enrollment Completed (479 patients) Prospective, randomized, double-blind, placebo-controlled, transrectal treatment of PRX302, which will utilize the IPSS outcome measure evaluated at 12 months as the primary endpoint
PRX302-2-7 PCa

 

IIa Enrolling (approximately 20 patients) Open label, Phase 2a study, evaluating the safety and tolerability of targeted intraprostatic administration of PRX302 to treat men with histologically proven, clinically significant, localized, low to intermediate risk prostate cancer


Completed Clinical Development
 

Study Phase
(pts treated with PRX302
Trial Design
TRIUMPH
PRX302-2-03 BPH
IIb (61 pts) Randomized, double-blind, placebo-controlled, transperineal treatment of PRX302
PRX302-2-06 BPH I/II (32 pts) Randomized dose escalation, multicenter trial of a single transrectal intraprostatic treatment of PRX302
PRX302-2-02
Phase 2a BPH
IIa (18 pts) Open-label, safety, volume escalation clinical trial of a single transperineal treatment of PRX302
PRX302-2-01
BPH
I (15 pts) Open-label, safety, dose escalation clinical trial of a signal transperineal intraprostatic treatment of PRX302
PRX302 PCa I (24 pts) Open-label, safety and tolerability, dose escalation trial of PRX302 in patients with biopsy-proven, locally-recurrent prostate cancer
PRX302 PCa II (6 pts) Open-label clinical trial in locally-recurrent prostate cancer


$SPHS was $40.00 in 2011 We will be back there soon enough.
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SPHS News: Sophiris Bio to Present at 28th Annual Piper Jaffray Healthcare Conference 11/22/2016 08:00:00 AM
SPHS News: Quarterly Report (10-q) 11/09/2016 04:25:40 PM
SPHS News: Current Report Filing (8-k) 11/09/2016 04:15:19 PM
SPHS News: Sophiris Bio Reports Third Quarter 2016 Financial Results and Key Business Highlights 11/09/2016 04:01:00 PM
SPHS News: Statement of Changes in Beneficial Ownership (4) 10/31/2016 05:12:15 PM
PostSubject
#2668   Nice move today!!!! News in the pipeline? Anyone Fuddynut 11/29/16 11:38:33 AM
#2667   Great summary for a buyout ... nymostwanted 11/21/16 09:01:32 PM
#2666   Great info. But, sounds like other than a K-Pax 11/21/16 08:29:31 PM
#2665   Sphs is currently in search of funding for HeresJonny 11/21/16 04:27:35 PM
#2664   Are there any trials currently under way? Does K-Pax 11/21/16 09:19:22 AM
#2663   Do you have a Link or a source djpope 11/20/16 12:02:13 PM
#2662   Thanks, I wonder though if there is any rosemountbomber 11/20/16 10:32:48 AM
#2661   The company has reportedly commenced putting in place melaurian 11/20/16 08:40:17 AM
#2660   Buyout is imminent:) nymostwanted 11/19/16 07:54:53 PM
#2659   Let's see if you can still tell us djpope 11/19/16 11:22:04 AM
#2658   There isn't one ABNYC 11/18/16 08:53:56 PM
#2657   I don't know if the FDA requires 2 rosemountbomber 11/18/16 09:03:15 AM
#2656   When is the buyout larlar206 11/18/16 04:56:04 AM
#2655   Just FTI, my understanding 2 P3s are generally Optionsrbest4u 11/17/16 04:47:40 PM
#2654   why would i be kidding? it's a question coopswag45 11/17/16 10:34:29 AM
#2653   You're kidding right? ABNYC 11/16/16 08:37:39 PM
#2652   Well you touched on a key point that rosemountbomber 11/15/16 01:25:22 PM
#2651   More SPHS News Views and Commentary; https://investing101dot.wordpress.com/2016 melaurian 11/12/16 07:38:55 PM
#2650   they need to do that because FDA considers lumi007 11/10/16 04:46:37 PM
#2649   what is SPHS next move with BPH drug blackbandit 11/10/16 03:24:01 PM
#2648   I think so, but when is the question. claymore 11/10/16 12:52:42 PM
#2647   buyout imminent? coopswag45 11/10/16 12:21:25 PM
#2646   I believe earnings the 14th maybe some news nymostwanted 11/06/16 01:20:13 PM
#2645   Totally agree. Recent offering at $4 and now joev2 11/03/16 10:38:10 AM
#2644   Low floater and low outstanding any good news nymostwanted 11/01/16 10:02:50 PM
#2643   https://youtu.be/I0InJiy2hIQ nymostwanted 11/01/16 09:53:40 PM
#2642   SPHS News, Views & Commentary: https://investing101dot.wordpress.com/2016/07/01 melaurian 10/29/16 10:02:51 AM
#2641   Let's go SPHS, wanna see this burst to nymostwanted 10/25/16 04:28:05 PM
#2640   agree SPHS showing buying strength the last few blackbandit 10/20/16 10:45:21 AM
#2639   At some point we will have to break nymostwanted 10/19/16 10:39:52 AM
#2638   I won't be surprised to see $4 by nymostwanted 10/19/16 10:39:15 AM
#2637   added to watchlist mikekrane 10/18/16 08:42:53 AM
#2636   Interesting....excellent post mate. Optionsrbest4u 10/17/16 11:53:49 AM
#2635   New Board Member appointed at SPHS, filing here melaurian 10/15/16 04:05:02 PM
#2634   SPHS green 3 of last 4 days. maybe blackbandit 10/14/16 10:13:44 AM
#2633   Common prostate cancer treatment linked to dementia risk djpope 10/13/16 06:09:50 PM
#2632   SPHS has closed green 2 days in a blackbandit 10/11/16 04:39:28 PM
#2631   has SPHS stated when they plan to file blackbandit 10/10/16 08:38:54 PM
#2630   they just added 26mil$$ to the coffers a blackbandit 10/07/16 01:37:00 PM
#2629   You really haven't done any DD have you. Ortho91 10/07/16 01:07:30 PM
#2628   Is the SPHS cash position as dire as Optionsrbest4u 10/07/16 12:10:44 PM
#2627   Wow I said bull. Bear flag my mistake hwpbnj 10/07/16 07:35:50 AM
#2626   most all small bio's red so far today. blackbandit 10/06/16 02:49:22 PM
#2625   Can't hold above 3 bucks anymore. hwpbnj 10/06/16 01:59:04 PM
#2624   Slowly bleeding. Bull flag formed. Should have listened hwpbnj 10/06/16 01:58:09 PM
#2622   Stocks relying on news isn't good enough to hwpbnj 10/05/16 03:19:51 PM
#2621   Actually it's looking bad. Stop telling people this hwpbnj 10/05/16 03:17:49 PM
#2620   drop before news release? ming1234 10/05/16 10:35:10 AM
#2619   agree, welcome and looks like strong support around blackbandit 10/05/16 10:33:36 AM
#2618   its riding the $3 consolidation line now. Will blackbandit 10/05/16 09:53:22 AM
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